REGULATORY ASPECT OF PHARMACEUTICAL CHANGE CONTROL SYSTEM
Abstract
The change control is “A process that ensures that changes to materials; methods, equipment and software are properly documented, validated, approved and traceableâ€. The process requires eight basic steps: Identification, documentation review, change proposal, change classification, implementation plan, installation, verification, closure. Changes are outlines as Major, Moderate & Minor. A compliance of regulatory group within the company determines the filing impact and submits it to FDA,-A prior- Approval supplement (PAS) for major changes, A CBE -30 or CBE-0 for moderate changes or Annual report for Minor changes. Firms are expected to write adequate SOP for the change control & be in total compliance with proper documentation. Considering the regulatory prospective of change control procedures, it is important to note that there are many guideline which describe the control of changes in manufacturing few references includes 21 CFR Part 211: Sec. 211.100, 21 CFR Part 211.194 (Laboratory Records), ICH Q7A and USFDA Guidance for Industry: Change to an approved NDA or ANDA (April 2004- Revison-1).
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